3 research outputs found
Executive Functions Are Associated with Fall Risk but not Balance in Chronic Cerebrovascular Disease
Background: Older people’s deficits in executive functions (EF) have been shown to lead to higher fall risk, postural sway, and reduced speed. Crucially, EF impairments are even more pronounced in individuals with chronic cerebrovascular disease (CVD), namely vascular cognitive impairment. Methods: In this retrospective cross-sectional study, we used a complete neuropsychological battery, including the Trail Making Test (TMT) and physical measures, such as the Morse fall and EQUI scales, to assess 66 individuals with chronic CVD. Linear regressions, Bayesian analyses, and model selection were performed to see the impact of EF, global cognition, and vascular parkinsonism/hemiplegia on physical measures (fall risk and balance). Results: The TMT part B and BA correlated (r = 0.44 and r = 0.45) with Morse fall scale. Only EF significantly explained fall risk, whereas global cognition and vascular parkinsonism/hemiplegia did not. These findings were confirmed by Bayesian evidence and parsimony model selection. Balance was not significantly correlated with any of the neuropsychological tests. Conclusions: This is the first study investigating the relationship between cognitive and physical measures in a sample of older people with chronic CVD. The results are consistent with previous findings that link EF with fall risk in CVD
Comparative study of esketamine and racemic ketamine in treatment-resistant depression: Protocol for a non-inferiority clinical trial
Carvalho, Lucas Pedreira de. Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. LaboratĂłrio de Pesquisa ClĂnica. Salvador, BA, Brasil. a Postgraduate Program in Medicine and Health, b Psychiatry Service, University Hospital, Universidade Federal da Bahia, Salvador, c LiNCâLaboratĂłrio Interdisciplinar
de NeurociĂȘncias ClĂnicas, d Depatment of Anesthesiology, e PRODAFâPrograma de Transtornos Afetivos, Universidade Federal de SĂŁo Paulo, SĂŁo Paulo,
f Postgraduate Program in Psychology, Institute of Psychology, g Immunology Service, Universidade Federal da Bahial, h Clinical Research Laboratory (LAPEC), Gonçalo
Moniz Institute, Fiocruz-Bahia, Salvador, Brazil, i McGill Group for Suicide Studies, Douglas Mental Health University Institute & Department of Psychiatry, McGill
University, Montreal, Canada, j Center for Research and Clinical Trials Sinapse-Bairral, Instituto Bairral de Psiquiatria, Itapira, Brazil.Submitted by Ana Maria Fiscina Sampaio ([email protected]) on 2018-12-21T16:28:46Z
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Previous issue date: 2018Allergan and Lundbeck and research fees from Janssen Pharmaceutical during the last 12 months. ALTL has received
consulting fees from Janssen Pharmaceutical, Daiichi Sankyo Brasil, Cristalia Produtos QuĂmicos e FarmacĂȘuticos, Libbs FarmacĂȘutica and SanofiAventis and has
received research fees from Eli Lilly, H. Lundbeck A/S, Servier Laboratories, Hoffman-La Roche and Forum Pharmaceuticals during the last 12 months.MĂșltipla - ver em NotasThe use of ketamine as an option in the treatment of depressive disorder is growing rapidly, supported by numerous clinical trials attesting its efficacy and safety. Esketamine, the S (+) enantiomer of ketamine, is the most widely used form in the anesthetic environment in some countries, and new studies have shown that it may also be effective in depression and with better tolerability. However, no study so far has directly compared esketamine with racemic ketamine. Here we propose a protocol of a clinical trial to evaluate esketamine as a noninferior medicationMethods/design: This study protocol is for a randomized, controlled, double-blind noninferiority clinical trial. Subjects will be 18
years or older, with major depression characterized as treatment-resistant. Participants will receive a single infusion of either
esketamine (0.25mg/kg) or ketamine (0.5 mg/kg) over 40 minutes. The primary outcome will be the difference in remission rates
between the 2 treatment arms at 24 and 72hours after drug infusion. Secondary outcomes will include other timepoints,
measurements of cognition, dissociation, and blood biomarkers.
Discussion: A head-to-head study is the best way to evaluate whether the esketamine is in fact comparable to the racemic
ketamine in terms of both efficacy and safety, and, if positive, it would be an initial step to increase the access to that type of treatment
worldwide.
Ethics and dissemination: The study was approved by the local Institutional Review Board (University Hospital Professor
Edgard SantosâFederal University of BahiaâNumber: 46657415.0.0000.0049). Subjects will only participate after voluntarily
agreeing and signing the Informed Consent Form. The study findings will be published in peer-reviewed journals and presented at
national and international conferences.
Trial registration: This trial has been registered in the Japan Primary Registries Network (JPRN): UMIN000032355, which is
affiliated with the World Health Organization. when compared to ketamine in the treatment of patients with treatment-resistant depression